Conformity Magazine - April 2008 - (Page 16)

and dusts (Da, Db and Dc), and are equivalent to the ATEX Categories 1, 2 and 3. IEC 60079-0 (5th Ed) will be adopted as EN 60079-0 during 2008 and harmonised for ATEX purposes. The ATEX Conformity Assessment Procedure Once the required ATEX equipment category has been established, then the process of proving the safety of the equipment can begin. Depending on the category and technology, the manufacturer may be required to use an ATEX Notified Body to certify their equipment. The certification process and the role of the Notified Body are defined by the conformity assessment procedures as set out in Annexes III to IX of the ATEX Product Directive (see Table 2). The conformity assessment procedures define the rules for ATEX compliance of a particular category of equipment. It should be noted that, where more than one category is present, the highest category defines the conformity assessment procedure for the whole equipment. Evaluating Equipment All categories of ATEX equipment must be demonstrated as being safe. This is achieved through compliance with the essential health and safety requirements (EHSRs) listed in Annex II of the ATEX Product Directive. Whilst there is no legal requirement to apply one of the ATEX harmonised EN Category 1G or 1D Zone 0 Evaluation stage standards, this is the usual method used. These standards can provide a presumption of conformity with the EHSRs and hence are an easy way of proving compliance. The latest set of ATEX standards are defined by the EN 60079 series for electrical equipment used in gas environments, the EN 61241 series for electrical equipment used in dust environments, and the EN 13463 series for mechanical equipment for use in either gas or dust environments. The electrical standards are heavily based on the corresponding international IEC series; hence, compliance with ATEX can also provide a path to compliance outside of the European Union. Some of the newer UL and CSA hazardous area equipment standards are also based on the same common IEC 60079 documents (e.g., UL 60079-0). It is worth noting that many of the EN standards have recently been published or re-issued, and have replaced earlier series of ATEX standards (e.g., the old EN 500xx series). Whilst existing equipment may still use the older series of standards for ATEX compliance, new equipment should comply with the latest EN standards. A list of the commonly used current EN standards is given in Table 3. A copy of the full list of standards is available in the ATEX section of the Europa web site. It should be noted that the EHSRs are the Production control stage Either Production QA (Annex IV) – factory inspection by Notified Body (based on ISO9001) leading to issue of a Quality Assurance Notification Or Product verification (Annex V) – product test and inspection by Notified Body at factory leading to issue of a Quality Assurance Notification Electrical or non-electrical equipment for series production - EC Type Examination by Notified Body (Annex III) leading to issue of an EC Type Examination Certificate Electrical or non-electrical equipment for bespoke production - unit verification by Notified Body (Annex IX) of single sample only (no factory inspection required) leading to issue of a Unit Verification Certificate 2G or 2D Zone 1 Electrical equipment for series production - EC Type Examination by Notified Body (Annex III) leading to issue of an EC Type Examination Certificate Either Conformity to type (Annex VI) – factory and test inspection by Notified Body leading to issue of a Quality Assurance Notification Or Product QA (Annex VII) – factory inspection by Notified Body (based on ISO9001) leading to issue of a Quality Assurance Notification Non-electrical equipment for series production Internal Production Control by manufacturer (Annex VIII) and send the technical file to a Notified Body. Electrical or non-electrical equipment for bespoke production - unit verification by Notified Body (Annex IX) of single sample only (no factory inspection required) leading to issue of a Unit Verification Certificate 3G or 3D Zone 2 (see note) Electrical or non-electrical equipment for series or bespoke production - test report produced by manufacturer or any competent person Internal Production Control by manufacturer (Annex VIII) Option for electrical or non-electrical equipment for bespoke production - unit verification by Notified Body (Annex IX) of single sample only (no factory inspection required) leading to issue of a Unit Verification Certificate Note: Category 3 equipment can be self certified by the manufacturer, although many purchasers may still prefer a third-party certification. Issue of an EC Type Examination Certificate or Quality Assurance Notification is not permitted for category 3 equipment. Table 2: ATEX Conformity Assessment Annexes 1 Conformity April 2008

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Conformity Magazine - April 2008 NewsBreaks Editor’s Note Mandatory Analog Cellular Service Ends FCC Releases Quarterly Reports on Consumer Inquiries and Complaints New Standards List Released for The EU’s Low Voltage Directive FDA Issues Notification on Unretrieved Device Fragments FDA Offers Guidance on Waivers for In-Vitro Diagnostic Devices ESD Open Forum Emerging Issues in Standards Challenges in Testing Design Fundamentals Focus on... New Products Product Reviews Premarket Approval Application Guidance Issued by FDA New Jersey Enacts Electronic Waste Recycling Regulations A New U.S. Standard for Workstation and Computer Design Might the CPSC Hold Retailers Accountable for Safe Products? CPSC Loses “Sole Toy Tester” CPSC Actions in the News IEC Standards Update UL Standards Update Telcordia Standards Update From Our “You Can’t Make This Stuff Up” Department Looking Back: Items from Past Issues of Conformity Advertisers

Conformity Magazine - April 2008

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